FDA Adverse Event
Malfunction
Summary report: N
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
MDR report key: 17521815
·
Received August 12, 2023
Report
- Report Number
- MW5128763
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- May 24, 2013
- Manufacturer
- ST. JUDE MEDICAL
- Product Code
- NIK
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
THIS LEAD WAS IMPLANTED ON (B)(6)2009 AND IS STILL IN ACTIVE USE. IT HAS BEEN REPORTED TO TECHNICAL SERVICES THAT THIS LEAD IS HAVING ISSUES REGARDING R WAVE. THE PHYSICIAN WAS DR.(B)(6) AT (B)(6)MEDICAL CENTER . THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 563772 | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | NIK | ST. JUDE MEDICAL | 1156T |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |